Impact of DNA Fragmentation in Sperm on Pregnancy Outcome After Intra-uterine Insemination in a Spontaneous Cycle

Infertility, Male Clinical Trial

Official title:

Impact of DNA Fragmentation in Sperm on Pregnancy Outcome After Intra-uterine Insemination in a Spontaneous Cycle

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03319654
• Other study ID #: UZA TBM -DNA IUI 2017
• Status: Completed
• Phase: N/A
• Start date: October 5, 2017
• Est. completion date: June 30, 2021

Study information

• Verified date: August 2021
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Infertility affects about 10% of all couples and is defined by a failure to achieve a clinical pregnancy within a year of regular unprotected sexual intercourse. Up to one third of these couples will not have an identifiable cause after routine investigation, id est idiopathic infertility. The current diagnosis of male infertility relies on the World Health Organization (WHO) 2010 criteria which focus on concentration, motility and morphology in comparison to cut-off values of a fertile population. Alas, the relevance of the conventional semen analysis for the choice of treatment and the predictive value for an infertile couple with idiopathic or mild male infertility embarking on medically assisted reproduction (MAR) remains questionable. In other words, there is a strong clinical need to distinguish fertile from infertile men through new sperm function testing and to be able to select both the patient population who will benefit from MAR as well as the type of treatment.

Numerous studies utilizing different techniques for assessing sperm DNA fragmentation support the existence of a significant association between sperm DNA damage and pregnancy outcomes.

In this prospective cohort study the investigators aim to study the role of sperm DNA fragmentation analysis in selecting the patient who will benefit from intra-uterine insemination (IUI) therapy since IUI is still considered the first step in MAR and is performed at a large scale in Belgium and worldwide.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 30, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

Couples seeking fertility treatment after at least 12 months of unprotected intercourse are eligible. All couples underwent basic fertility investigations which included semen analysis, evaluation of menstrual cycle, and tubal patency testing.

Exclusion Criteria:

Double sided tubal disease, severe endometriosis (classified as revised American Society for Reproductive Medicine stage III or IV), premature ovarian failure, and known endocrine disorders (such as Cushing's syndrome or adrenal hyperplasia), azoö- or necrozoospermia

Related Conditions & MeSH terms

• DNA Damage
• Infertility
• Infertility Unexplained
• Infertility, Male

Intervention

Diagnostic Test:
• DNA fragmentation by TUNEL assay
Direct DNA fragmentation testing with terminal deoxyuridine nick end labeling (TUNEL) assay.

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Antwerpen	Edegem	Antwerp

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Antwerp	Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DNA fragmentation as a predictor of clinical pregnancy and live birth rate	DNA fragmentation as evaluated by TUNEL assay.	up to 36 months
Secondary	DNA fragmentation in the total and vital fraction before and after density gradient in the diagnostic sample (pre-IUI)	DNA fragmentation as evaluated by TUNEL assay	up to 36 months
Secondary	DNA fragmentation in the total and vital fraction before and after density gradient in the therapeutic sample (IUI sample)	DNA fragmentation as evaluated by TUNEL assay	up to 36 months
Secondary	DNA fragmentation in relation to the cumulative clinical pregnancy and cumulative live birth rate	DNA fragmentation as evaluated by TUNEL assay.	up to 36 months